[Federal Register Volume 67, Number 247 (Tuesday, December 24, 2002)]
[Rules and Regulations]
[Pages 78354-78356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32345]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, and 524
New Animal Drugs; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for 25 approved new
animal drug applications (NADAs) from American Cyanamid to Fort Dodge
Animal Health.
DATES: This rule is effective December 24, 2002.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: American Cyanamid, Division of American Home
Products, P.O. Box 1339, Fort Dodge, IA 50501, has informed FDA that it
has transferred ownership of, and all rights and interest in, the
following 25 approved NADAs to Fort Dodge Animal Health, Division of
American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501:
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NADA Number Trade Name
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006-084 SULMET Drinking Water
Solution
008-774 SULMET Solution Injectable
011-582 VETAMOX Soluble Powder
011-644 FELAC
013-957 S.E.Z. Drinking Water 6.25%
015-160 Sodium Sulfachloropyrazine
Solution
033-342 PROBAN Cythioate Tablets 30 mg
033-606 PROBAN Oral Liquid
033-653 S.E.Z. Drinking Water Solution
033-654 S.E.Z. Oblets 15 g
033-655 S.E.Z. Intravenous Solution
047-033 S.E.Z. C-R Oblets 15 g
055-012 AUREOMYCIN Sulmet Soluble Powder
055-018 AUREOMYCIN Tablets 25 mg
055-020 AUREOMYCIN Soluble Powder
055-039 AUREOMYCIN Soluble Oblets
065-071 AUREOMYCIN Soluble Powder
065-269 POLYOTIC Soluble Powder
065-270 POLYOTIC Oblets
065-313 BACIFERM Soluble 50
065-440 AUREOMYCIN Soluble Powder Concentrate
065-441 POLYOTIC Soluble Powder Concentrate
122-271 SULMET Oblets
122-272 SULMET Soluble Powder
[[Page 78355]]
140-844 TRAMISOL Pour-On
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Accordingly, the agency is amending the regulations in 21 CFR 520.44,
520.154c, 520.445a, 520.445b, 520.445c, 520.530, 520.531, 520.2184,
520.2240a, 520.2240b, 520.2260a, 520.2261a, 520.2261b, 520.2345c,
520.2345d, 522.940, 522.2240, 522.2260, and 524.1240 to reflect the
transfer of ownership and to reflect current format.
Following this change of sponsorship, American Cyanamid is no
longer the sponsor of any approved application. Accordingly, 21 CFR
510.600(c) is being amended to remove the entries for American
Cyanamid.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, and 524 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
2. Section 510.600 Names, addresses, and drug labeler codes of
sponsors of approved applications is amended in the table in paragraph
(c)(1) by removing the entry for ``American Cyanamid'' and in the table
in paragraph (c)(2) by removing the entry for ``010042''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.44 [Amended]
4. Section 520.44 Acetazolamide sodium soluble powder is amended in
paragraph (b) by removing ``010042'' and by adding in its place
``053501''.
Sec. 520.154c [Amended]
5. Section 520.154c Bacitracin zinc soluble powder is amended in
paragraph (b) by removing ``010042'' and by adding in its place
``053501''.
Sec. 520.445a [Amended]
6. Section 520.445a Chlortetracycline bisulfate/sulfamethazine
bisulfate soluble powder is amended in paragraph (b) by removing
``010042'' and by adding in its place ``053501''.
Sec. 520.445b [Amended]
7. Section 520.445b Chlortetracycline powder (chlortetracycline
hydrochloride or chlortetracycline bisulfate) is amended in paragraphs
(b) and (d)(4)(iii)(C) by removing ``010042'' and by adding in its
place ``053501''.
Sec. 520.445c [Amended]
8. Section 520.445c Chlortetracycline tablets and boluses is
amended in paragraph (b) by removing ``010042'' and by adding in its
place ``053501''.
Sec. 520.530 [Amended]
9. Section 520.530 Cythioate oral liquid is amended in paragraph
(b) by removing ``010042'' and by adding in its place ``053501''.
Sec. 520.531 [Amended]
10. Section 520.531 Cythioate tablets is amended in paragraph (b)
by removing ``010042'' and by adding in its place ``053501''.
Sec. 520.2184 [Amended]
11. Section 520.2184 Sodium sulfachloropyrazine monohydrate is
amended in paragraph (b) by removing ``010042'' and by adding in its
place ``053501''.
Sec. 520.2240a [Amended]
12. Section 520.2240a Sulfaethoxypyridazine drinking water is
amended in paragraph (c) by removing ``010042'' and by adding in its
place ``053501''.
Sec. 520.2240b [Amended]
13. Section 520.2240b Sulfaethoxypyridazine tablets is amended in
paragraph (c) by removing ``010042'' and by adding in its place
``053501''.
Sec. 520.2260a [Amended]
14. Section 520.2260a Sulfamethazine oblet, tablet, and bolus is
amended in paragraph (a)(1) by removing ``010042'' and by adding in its
place ``053501''.
Sec. 520.2261a [Amended]
15. Section 520.2261a Sulfamethazine sodium drinking water solution
is amended in paragraph (a) by removing ``010042'' and by adding in its
place ``053501''.
Sec. 520.2261b [Amended]
16. Section 520.2261b Sulfamethazine sodium soluble powder is
amended in paragraph (a) by removing ``010042'' and by adding in its
place ``053501''.
Sec. 520.2345c [Amended]
17. Section 520.2345c Tetracycline boluses is amended in paragraph
(b) in the first sentence by removing ``010042'' and by adding in its
place ``053501''.
Sec. 520.2345d [Amended]
18. Section 520.2345d Tetracycline hydrochloride soluble powder is
amended in paragraphs (a)(3), (d)(1)(iii), and (d)(2)(iii) by removing
``010042'' and by adding in its place ``053501''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
19. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.940 [Amended]
20. Section 522.940 Colloidal ferric oxide injection is amended in
paragraph (c)(1) by removing ``010042 and 017800'' and by adding in its
place ``017800 and 053501''.
Sec. 522.2240 [Amended]
21. Section 522.2240 Sulfaethoxypyridazine is amended in paragraph
(c) by removing ``010042'' and by adding in its place ``053501''.
Sec. 522.2260 [Amended]
22. Section 522.2260 Sulfamethazine injectable solution is amended
in paragraph (b) by removing ``010042'' and by adding in its place
``053501''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
23. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1240 [Amended]
24. Section 524.1240 Levamisole is amended in paragraph (b) by
removing ``010042'' and by adding in its place ``053501''.
[[Page 78356]]
Dated: November 8, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 02-32345 Filed 12-23-02; 8:45 am]
BILLING CODE 4160-01-S